RecruitingPhase 4ACTRN12607000202460

Oxygen therapy and myocardial ischaemia during exercise testing

A double blind randomised controlled cross-over trial of the effect of high flow oxygen on myocardial ischaemia during exercise treadmill testing (ETT)


Sponsor

Dr Mark Simmonds

Enrollment

20 participants

Start Date

Apr 13, 2007

Study Type

Interventional

Conditions

Summary

It is routine clinical practice to administer high flow oxygen to all patients with a heart attack. However, there is evidence to suggest that this approach may be harmful, particularly to those patients who are not hypoxic. High flow oxygen causing hyperoxia has been shown to increase blood pressure and reduce cardiac output, and possibly also reduce coronary artery blood flow. As a result it is crucial that the effects of high flow oxygen on myocardial ischaemia is investigated further in patients with ischaemic heart disease. A double-blind randomised controlled cross-over trial using exercise treadmill testing is an ideal method to measure the effect of supplementary oxygen on myocardial ischaemia.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with coronary artery disease (reduced blood flow to the heart) who experience chest pain during exercise testing (called an exercise treadmill test, or ETT). Standard practice routinely gives these patients high-flow oxygen, but this may not always be helpful — and it may even reduce blood flow to the heart in some cases. This study uses a careful crossover design to test the effect of high-flow versus controlled oxygen on the heart during exercise. You may be eligible if: - You are 18 years of age or older - You have been shown to have inducible heart ischaemia (reduced blood flow to the heart) with chest pain during an exercise treadmill test You may NOT be eligible if: - Your resting heart tracing (ECG) is abnormal - You have unstable angina (chest pain at rest, daily) - You have congestive heart failure - You have severe high blood pressure (systolic above 200 mmHg) - You have COPD or another lung condition with low oxygen levels at rest - You have a contraindication to aspirin, metoprolol, or simvastatin Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will receive two oxygen regimes in a cross over fashion: room air (placebo) for 5 minutes before the start and continued until the end of the ETT, and high flow oxygen (15/L minute) (comparat

Patients will receive two oxygen regimes in a cross over fashion: room air (placebo) for 5 minutes before the start and continued until the end of the ETT, and high flow oxygen (15/L minute) (comparator) via a non-rebreather mask for 5 minutes before the start and continued until the end of the ETT. The order that the regimes are received will be allocated randomly and there will be approximately 90 minutes between tests. Exercise will be standardised according to the Bruce protocol for exercise stress tests. The ETT will be stopped for any of the following reasons ST elevation, LBBB or arrhythmia occurs The patient requests to stop the test The development of diagnostic ECG ischaemia for 15 seconds The cardiology registrar determines that the ETT should be stopped If none of these endpoints are reached then the duration of the ETT will be determined by the exercise capacity of the patient.


Locations(1)

New Zealand

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ACTRN12607000202460